The following data is part of a premarket notification filed by Endo Lase, Inc. with the FDA for Model 700 Evacuator For Use With Laser Surgery.
| Device ID | K860152 |
| 510k Number | K860152 |
| Device Name: | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY |
| Classification | Laser For Gastro-urology Use |
| Applicant | ENDO LASE, INC. ATTN: JONATHAN S. KAHAN 815 CONNECTICUT AVENUE Washington, DC 20006 |
| Contact | & Hartson |
| Correspondent | & Hartson ENDO LASE, INC. ATTN: JONATHAN S. KAHAN 815 CONNECTICUT AVENUE Washington, DC 20006 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-15 |
| Decision Date | 1986-02-05 |